Regulus Therapeutics, Inc. (NASDAQ:RGLS) Q2 2022 Earnings Conference Call August 11, 2022 5:00 PM ET

Company Participants

Crispina Calsada - CFO

Joseph Hagan - President & CEO

Conference Call Participants

Yi Chen - H.C. Wainwright & Co.

Operator

Good morning, and welcome to the Regulus Therapeutics Second Quarter Financial Results Conference Call.

All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Cris Calsada, Chief Financial Officer of Regulus. Please go ahead.

Crispina Calsada

Thank you. Good afternoon, everyone, and thank you for joining us to discuss Regulus Therapeutics Second Quarter 2022 Financial Results and Corporate Highlights. Joining me on today's call is Jay Hagan, President and Chief Executive Officer; and Dr. Denis Drygin, Chief Scientific Officer. Jay will provide opening remarks and share progress on our ADPKD and other programs, and I will review the financial results before we open the line for questions.

Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning Regulus Therapeutics' future expectations, plans, prospects, corporate strategy and performance, which constitute forward-looking statements for the purpose of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.

I'll now turn the call over to Jay.

Joseph Hagan

Thanks, Cris, and welcome everyone, to our second quarter earnings call and business update. I'll begin first with a general update on our ADPKD program.

The second quarter was particularly eventful, beginning with the US Food and Drug Administration's acceptance of our IND for RGLS8429 for the treatment of autosomal dominant polycystic kidney disease. This was followed by the dosing of the first subject in our Phase 1 single ascending dose study of RGLS8429 to assess the safety, tolerability in pharmacokinetics of the drug in healthy volunteers.

Following this study, we plan to initiate a Phase 1B multiple ascending dose study in adult patients with ADPKD to assess the safety, tolerability and pharmacokinetics of RGLS8429 treatment, as well as to evaluate the dose response of RGLS8429 on ADPKD biomarkers, including polycystins, cystic kidney volume and overall kidney function.